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EC number: 202-509-5
CAS number: 96-48-0
Skin irritation: negative
Eye Irritation: causes irreversible effects
(GBL) has been adequately tested for skin and eye irritation and found
to not be a skin irritant but is capable of causing irreversible effects
in the eye. When applied to clipped Vienna White rabbits and occluded,
mean Erythema and Edema scores were 0 out of 4 after 24, 48, and 72
hours (BASF AG, 1960). When applied to an eye of a single New Zealand
White rabbit in an OECD 405 guideline study under GLP conditions,
effects on the cornea were observed (BASF AG, 2005). The mean cornea
score was 1.3 out of 4 after 24, 48, and 72 hours, and were not
fully reversible after 28 days. Similar results were observed in an
earlier study of similar design (BASF, 1960) and are further supported
by several in vitro tests. However, another OECD 405 guideline
study, under GLP conditions, reported in the European Centre for
Ecotoxicology and Toxicology of Chemicals (ECETOC) Technical Report No.
48 (Version 2), indicated that effects observed in the cornea were
reversible within 14 days (ECETOC, 1998), but some details of the study
design were not available for review. GBL should be regarded as an eye
irritant capable of causing irreversible effects.
Effects on eye irritation: irritating
the results of the key study (Draize score = 0 after 24, 48 and 72 hours
under occlusive conditions), gamma-butyrolactone would not be classified
as a primary dermal irritant under the EU DSD criteria (EU Directive
67/548/EEC) or under the EU CLP criteria (EU Regulation 1272/2008).
applied to the eye of a rabbit, effects on the cornea were observed. The
mean cornea score was 1.3 out of 4 after 24, 48, and 72 hours and was
not fully reversible after 28 days. Based on the results of the key
study gamma-butyrolactone would be classified as Xi; R41 (Risk of
serious damage to eyes) under the EU DSD criteria (EU Directive
67/548/EEC). Gamma-butyrolactone also meets the criteria for
classification as a Category 1 eye irritant (Causes serious eye damage)
under the EU CLP criteria (EU Regulation 1272/2008) because the effects
were not fully reversible after 28 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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